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PhaseI/II study of carboplatin plus nab-paclitaxel plus bevacizumab administered to advanced non-squamous non-small cell lung cancer.

Phase 1
Recruiting
Conditions
advanced non-squamous non-small cell lung cancer
Registration Number
JPRN-UMIN000013333
Lead Sponsor
agoya City West Medical Center
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Recruiting
Sex
All
Target Recruitment
35
Inclusion Criteria

Not provided

Exclusion Criteria

(1) Hemorrhagic Diathesis, coagulopathy (2) Presence of cardiovascular invasion (3) Presence of any tumor with cavitation (4) Presence of significant interstitial lung disease or lung fibrosis (5) Uncontrolled intercurrent illness (eg. hypertension, diabetes mellitus, gastro- intestinal fistula, symptomatic congestive heart failure, unstable angina pectoris, serious cardiac arrhythmia) (6) Ongoing/active infection (7) Arterial thrombotic events or significant vascular disease (8) Uncontrolled gastric ulcer (9) Gastrointestinal perforation within the past 12 months (10) Prior malignancy (11) Uncontrolled pleural effusion or ascites (12) Clinically significant pericardial effusion (13) Hypersensitivity history for test drugs (14) Pregnancy or breast-feeding

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
phase I: to determine recommended dose phaseII: response rate
Secondary Outcome Measures
NameTimeMethod
phaseII:to evaluate disease control rate, progression free survival, overall survival and safety profile
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